A Study of Weekly Docetaxel Plus Cisplatin Followed by Gemcitabine vs. Gemcitabine Plus Cisplatin Followed by Weekly Docetaxel in the Treatment of Advanced Non-Small-Cell Lung Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Primary to evaluate the 1-year treatment failure rate of two sequential chemotherapy regimens:

1. weekly docetaxel plus cisplatin followed by gemcitabine and

2. gemcitabine plus cisplatin followed by weekly docetaxel. Study design:Prospective, multi-center, open-labelled, randomized phase II study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Far Eastern Memorial Hospital
• Treatments: Cisplatin; Docetaxel; Gemcitabine

Criteria

Inclusion Criteria:

• 1.Written informed consent prior to beginning specific protocol procedures including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements.

2. Histologically or cytologically proven non-small cell lung carcinoma. 3. Stage IIIB or IV disease, no curative treatment available, candidate for chemotherapy.

4. Age > 18 years and < 75 years. 5. Performance status WHO performance status 0,1. 6. Previous therapy:

(a) Chemotherapy: None. (b) Previous radiation therapy : prior irradiation for NSCLC is permitted, however, the measurable or evaluable non-measurable disease must be completely outside the radiation portal.

7. Unidimentional or bidimentional measurable disease. 8. Life expectancy > 12 weeks.

9. Laboratory requirements :

1. Hematology: Neutrophils * 1.5 109/l, Platelets * 100 109/l, Hemoglobin > 10 g/dl.

2. Hepatic function : Total bilirubin < 1.5 UNL, ASAT (SGOT) and ALAT (SGPT) < 2.5 UNL, Alkaline phosphatases < 5 UNL ; except in presence of only bone metastasis and in the absence of any liver disorders. Patients with ASAT and/or ALAT > 1.5 x UNL associated with alkaline phosphatase > 2.5 x UNL are not eligible for the study.

3. Renal function : Creatinine < 1 UNL, and creatinine clearance should be > 60 ml/min.

10.Complete initial lab studies within 2 weeks prior to first infusion, imaging studies within 4 weeks prior to first infusion.

11.Patients must be accessible for treatment and follow-up.

Exclusion Criteria:

• 1.Pregnant, or lactating patients; patients of childbearing potential must implement adequate contraceptive measures during study participation.

2. Symptomatic central nervous system metastasis, patients with asymptomatic brain metastasis can be accepted if the tumor is irradiated and do not need steroid to control symptom.

3. Pre-existing motor or sensory neurotoxicity of a severity > grade 1 by NCIC-CTG criteria.

4. Other serious illness or medical condition :

1. congestive heart failure or unstable angina pectoris. High risk uncontrolled arrhythmias.

2. history of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent.

3. active uncontrolled infection.

4. contraindication for the use of corticosteroids. 5. Past or current history of neoplasm other than non small cell lung cancer, except for curatively treated non melanoma skin cancer, in situ carcinoma of the cervix within 5 years.

6. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study entry.

7. Concurrent treatment with any other anti-cancer therapy.